Thanks to the FDA’s Priority Review program, hepatitis C medications are being approved at a faster rate! This program provides a fast-track review of medications that could that treat serious conditions like hepatitis C. New approvals over the past few years include Sovaldi, Harvoni, Viekira Pak, and we have another one to add to the list!
On July 18th, 2017, the FDA approved Vosevi, a new three drug combination medication for Hepatitis C. Vosevi is the first and only hepatitis C treatment specifically for patients who have tried advanced treatment and haven’t been cured.
What is Vosevi prescribed for?
Vosevi is a combination medication indicated for the treatment of chronic hepatitis C in adults, and is a second line treatment for all 6 types of hepatitis C genotypes.
It will be available as a combination tablet in the strength of 400 mg/100 mg/100 mg. The recommended dose is one tablet, every day with food, for twelve weeks.
What are the most common side effects associated with Vosevi?
Common side effects include headache, fatigue, diarrhea, and nausea. Be sure to speak with your doctor if you experience any of these side effects for a prolonged period of time.
Will Vosevi be a specialty medication?
Not sure. At this time there is no information stating that Vosevi will be considered a specialty medication; however, with all of the other Hepatitis C medications being specialty medications Vosevi will likely follow suit.
How much will Vosevi cost?
Gilead, the manufacturer, has not mentioned how much Vosevi will cost.
Epclusa, another hepatitis C medication manufactured by Gilead, is priced at $74,760 for a 12-week regimen. The cost of other 12-week hepatitis C medication regimens currently on the market such as Sovaldi and Harvoni cost $84,000 and $94,500 respectively. Therefore, it is expected that Vosevi will be priced right in line with the cost of these other treatments.
Gilead does offer a copay assistance program where eligible patients can pay as little as $5 per co-pay for Vosevi. To find out if you qualify, call 1-855-769-7284 to speak with a Vosevi Support Path specialist.
Doctors are often asked what ONE pill or supplement they would recommend, or take themselves. The answer to this, I have learned, depends on perspective—based on which specialty the physician practices. So, after 20 years of being surrounded doctors in many fields at an academic medical center, here is the one pill you should be taking, by specialty.
Aspirin, but not for everyone. Studies of aspirin for primary prevention of heart disease suggest about a 22% reduction in risk for non-fatal heart attack. Because aspirin increases the risk of gastrointestinal bleeding it’s not for everyone. The greatest benefit is seen in adults ages 50 to 59 with moderate to high cardiovascular risk, and those with risk factors like high blood pressure, high cholesterol, diabetes, family history of early heart disease, etc.
Runner up for this answer from a cardiologist would be a statin drug. Large clinical trials have shown statin therapy (atorvastatin, simvastatin, rosuvastatin) to be effective and safe for prevention of atherosclerotic cardiovascular disease (clogged arteries). Again, this holds true for adults ages 40 to 75 years, and in those who are eligible based on 10 year risk calculators—NOT everyone.
Gastroenterologist (“GI” Doctor)
Probiotics. Whether you struggle with lactose intolerance, irritable bowel syndrome, traveller’s diarrhea, Clostridium difficile (C. diff) diarrhea, or mild colitis symptoms, your GI doc will likely recommend probiotics in the form of fermented milk products (yogurt, kefir) or probiotic capsules (VSL #3, Align). Start with active culture yogurts or kefirs, but if you can’t tolerate dairy and need a supplement, look for one that contains multiple species (Lactobacillus, Bifidobacterium, etc) with high colony counts.
Runner up. For GI doctors who treat colon cancer patients, a daily aspirin may be recommended for the prevention of colon cancer. Two recent large studies have shown that the use of aspirin for 6 years or longer led to a 19% decreased risk of colorectal cancer and a 15% decreased risk of any type of gastrointestinal cancer. Again, given some of the risks associated with a daily aspirin, this isn’t for everyone.
Aspirin, but again, not for everyone. Stroke kills 133,000 Americans a year. For moderate and high-risk patients, studies of aspirin for prevention of stroke show it lowers your risk by approximately 14%. That’s pretty good given that aspirin costs pennies a day.
Runner up here would be a recommendation by neurologists who treat headache patients to try the supplements riboflavin 200 mg/day, magnesium 200 mg/day and CoQ10 75 mg/day which are available together as one supplement in Migrelief, Dolovent, or Migravent. The American Academy of Neurology recommends vitamin B2 (riboflavin), magnesium, and coenzyme Q10 for migraine prevention as alternatives to prescription drugs, given the desire for more natural treatment options and evidence that this supplement may reduce the number of headache days per month.
Ophthalmologist (Eye Doctor)
AREDS 2 vitamin. Taken once daily in those with intermediate to severe macular degeneration, the most common cause of blindness in the United States, an AREDS 2 combo vitamin available over the counter reduces the risk of progression of macular degeneration by as much as 19 percent, and of vision loss by 25 percent. Say what?! The AREDS 2 supplement is one of the only available treatments proven to be effective for intermediate-to-severe dry macular degeneration. What’s in AREDS 2? Lutein, zeaxanthin, vitamins E and C, zinc, and copper.
Skin doctors will say, in answer to the ONE thing their patients should be taking, a vitamin D capsule. Why? Because your dermatologist does not want you in the sun. Instead, they want you to get adequate vitamin D through a supplement (maintenance dose of approximately 2000 IU per day). Skin cancer is by far the most common type of cancer in adults and sun exposure is your major risk factor. They don’t want you to get that.
Vitamin D, again, but only in those with low vitamin D levels (hypovitaminosis D). Low vitamin D is associated with more severe osteoporotic hip fractures, and vertebral/spine fractures. Simply put, your orthopedic doctor wants you to have normal vitamin D levels, and to take vitamin D supplements to normalize them if you don’t.
Runner up would be a glucosamine plus chondroitin supplement in folks with knee osteoarthritis, though there have been conflicting results about whether or not they work.
A daily folic acid supplement for the prevention of neural tube defects is recommended for all women planning pregnancy or capable of becoming pregnant. The body of evidence from randomized trials and large studies supports a folic acid supplement of 0.4 mg taken once a day to decrease the occurrence of neural tube defects.
Metformin, and not only for the treatment of diabetes. Metformin in prediabetics helps prevent the onset of diabetes, improves weight loss, regulates ovulation in patients with polycystic ovary syndrome (PCOS), and may help you live longer. Not kidding. Animal studies (and ongoing studies in humans) have focused on metformin to reverse aging since it may influence fundamental aging factors that underlie multiple age-related conditions. Metformin 1000 mg a day is commonly embraced by endocrinologists and internists for those reasons.
Vaginal estrogens. For postmenopausal women with recurrent urinary tract infections, urinary incontinence, or atrophy, most urologists and urogynecologists will advise starting on a vaginal estrogen (Estrace cream, Premarin cream, or Vagifem tablets). Excluded from this advice will be women with a history of estrogen-receptor-positive breast cancer.
A helmet. It’s not a supplement, but a pediatricians mantra is: wear a helmet, wear your seatbelt, don’t ride a motorcycle, and don’t smoke. Unintentional injuries are the number one cause of death in the pediatric population and a helmet is your one thing in this case . . . not a pill or a supplement.
What did I miss?
Evidence from a large study in New Zealand for bacterial meningitis revealed an interesting finding – the meningitis B vaccine may help protect against gonorrhea. These findings are just observational though, and extensive clinical trials will need to be performed to ensure the effectiveness and safety of the vaccine.
Gonorrhea is a sexually transmitted infection caused by unprotected vaginal, anal or oral sex. It can be cured if properly treated, however, gonorrhea can cause complications like infertility, sepsis or arthritis if not treated.
On July 7th of this year, the World Health Organization (WHO) issued a news release that antibiotic-resistant gonorrhea is on the rise. With this resistance developing, it is expected that pharmaceutical companies will begin to explore forms of treatment such as vaccinations. Unfortunately, the vaccine that showed positive results for gonorrhea, MeNZB, is no longer available in the UK and has never been used in the United States.
It is too early to make assumptions about the use of the meningitis B vaccine, but this could be a step in the right direction towards preventing gonorrhea, especially amidst the emergence of bacterial resistance.
What is meningitis?
Meningitis is a life threatening infection that can cause inflammation of the brain and spinal cord membranes. Symptoms usually arise one week after exposure to the bacteria and include muscle pain, fever, lethargy, loss of appetite, nausea or vomiting. Currently, in the United States, there are three common forms of meningitis – B, Y, and C.
How can I protect myself against gonorrhea?
For now, the most effective way to prevent gonorrhea is to always use a condom during sex, even during oral or anal sex.
Are there any vaccinations available for sexually transmitted infections?
Yes. HPV is the most common sexually transmitted infection in the United States. The HPV vaccine can protect against disease (including cancer) caused by HPV, when given at the appropriate time. You can read more about the HPV vaccine, Gardasil, here.
Every three months, the FDA reviews and publishes reports of adverse reactions from medications they’ve received through the FDA Adverse Event Reporting System (FAERS). The FDA has been posting these quarterly updates since 2007, due to an update to the Food and Drug Administration Amendments Act that requires the FDA to publish a new list of potential signals of serious risks/new safety information identified every 3 months (see our overview of the previous list here).
Should I be worried if my prescription is on the list?
The FDA does emphasize that just because a medication appears this list, it doesn’t mean that the they have determined that the drug actually carries a risk. Following the quarterly update, the FDA will complete an evaluation of each potential safety issue and make additional announcements if they find anything further.
At the end of June 2017, the FDA released the list of medications for the first quarter (January – March) that potentially carry serious risks.
So which prescriptions is the FDA monitoring this quarter?
- Alli and Xenical (orlistat) are prescribed for weight loss. They are on the list due to reports of neuropsychiatric side effects (like mild cognitive impairment).
- Cubicin and Cubicin RF (daptomycin) are antibacterials (antibiotics) that appear on the list because of reports that confusion around the similar names causes prescribing and filling errors. To resolve the issue, the external package labeling has been updated, and the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations.
- Exjade and Jadenu (deferasirox) are prescribed for chronic iron overload, and they are on the list due to reports of fever and dehydration in children.
- Lupron (leuprolide), Lupron Depot PED (leuprolide), Supprelin LA (histrelin), and Synarel (nafarelin) are all used to treat central precocious puberty (CPP), a condition where girls under 8 years old and boys under 9 begin puberty too early. These prescriptions appear on the list due to reports of musculoskeletal and connective tissue pain and discomfort.
- Keppra (levetiracetam) products are typically used to treat seizures. They appear on the list due to reports of acute kidney injury and interstitial nephritis—a kidney condition characterized by swelling inside of the kidney. The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury.
- Keytruda (pembrolizumab), Opdivo (nivolumab), and Yervoy (ipilimumab) are used to treat certain cancers, and are on the list because of reports of adverse effects on the eye, including vision loss and retinal detachment.
- Kybella (deoxycholic acid) treats double chin by destroying fat cells under the chin. It’s on the list due to reports of injection site reactions and tissue death.
- Methimazole is typically used to treat overactive thyroid. It’s on the list due to reports of rhabdomyolysis, the breakdown of muscle tissue which can lead to kidney damage. The FDA decided no action is necessary at this time, based on available information.
- Neulasta (pegfilgrastim) is typically used the day after chemotherapy to boost your white blood cell count and help lower your risk for infection. It appears on the list for reports of device failure—the delivery device is applied to your skin at your chemo appointment and is designed to deliver Neulasta automatically the next day.
- Ofev (nintedanib) is used to treat a lung disease called pulmonary fibrosis, and it appears on the list due to reports of liver dysfunction.
- Farxiga (dapagliflozin), Glyxambi (empagliflozin/linagliptin), Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Invokamet XR (canagliflozin/metformin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Synjardy XR (empagliflozin/metformin), and Xigduo XR (dapagliflozin/
metformin) are all prescribed for the treatment of type 2 diabetes. Reports of kidney stones landed these diabetes meds on the list, but the FDA decided no action is necessary at this time, based on available information.
- Stelara (ustekinumab) is used to treat plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Interstitial pneumonia (a form of lung disease) has been reported by patients using Stelara.
- Tanzeum (albuglutide) and Trulicity (dulaglutide) are used for the treatment of type 2 diabetes, and appear on the list due to reports of serious hypersensitivity reactions.
- Uloric (febuxostat) is prescribed to treat gout. It appears on the list due to reports of reactions to the drug, including an increase in disease-fighting white blood cells, eosinophils, as well as various symptoms in other parts of the body.
What is the FDA doing about all of these reports?
Unless otherwise noted, the FDA is currently evaluating the need for further action on all of the medications on the list.
What should I do if I take one of these medications?
First, don’t stop taking your prescription without speaking to your doctor—this can cause more problems than it solves. If you have any concerns or if you think you’re experiencing one of these side effects, talk to your prescriber or pharmacist.
How can I report a problem with a drug to the FDA?
If you need to report a serious problem with a medication to the FDA, you can do so through their MedWatch website. The MedWatch website allows you to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can report suspected counterfeit medical products here as well.
Medications are a common offender when it comes to lower extremity edema, either as the cause or as a factor that can make it worse. Swelling in the lower legs from fluid in the tissues—lower extremity edema—is a familiar complaint among patients. Imprints from your socks, puffy legs and feet so you can’t put your shoes on, or swelling so that you can make an indent with your thumb (pitting edema) may lead you to wonder what’s going on.
One clue that your medication could be the cause: you have edema on both sides (it’s bilateral). Swelling from a clot in the leg, a “DVT” or deep venous thromboembolism, is usually on one side not both. Other causes of bilateral lower extremity edema is dependent edema (your legs have been in a dependent position for a while—sitting or standing for long periods of time), or more complex conditions like chronic venous disease, lymphedema, or heart failure.
If you do start to have lower extremity edema on both sides of your body, look at this list and make sure you aren’t taking one of these seven medications.
- Amlodipine (Norvasc) is a medication used to lower blood pressure. The higher the dose, the more likely you are to have swelling in both of your legs and feet. Edema occurs in 1.8% of folks taking 2.5 mg, 3% of folks taking 5 mg, and almost 11% of those taking 10 mg of amlodipine. So one in ten of you will have swelling when taking amlodipine 10 mg daily. More women taking amlodipine experience edema in their lower extremities: 15% of women compared to 5.6% of men. Other options exist for lowering blood pressure that don’t cause swelling in the legs, so if this is a problem for you, ask your doctor about switching up.
- Gabapentin (Neurontin) is used for the treatment of neuropathic pain—pain after a shingles outbreak (postherpetic neuralgia) or pain in the legs from diabetes (diabetic peripheral neuropathy). Gabapentin is also used for patients with fibromyalgia, epilepsy and restless leg syndrome. Gabapentin is a known cause of lower extremity edema. In postherpetic neuralgia trials, edema occurred in 8% of the gabapentin group.
- Pregabalin (Lyrica) may also cause swelling in the feet and legs. Lyrica, similar to gabapentin, is prescribed for neuropathic (nerve) pain, also associated with diabetic peripheral neuropathy and postherpetic neuralgia, as well as from spinal cord injury. Lyrica may also be prescribed for seizures and the treatment of fibromyalgia. It’s known to cause lower extremity edema.
- Ibuprofen (Motrin, Advil), naproxen (Aleve) and other nonsteroidal anti-inflammatory drugs (NSAIDs) are common over the counter medications used for pain and inflammation and are a well described cause of edema. In this case, it’s typically mild and reversible, caused by sodium retention.
- Oral contraceptives. This is tricky because the estrogen in many oral contraceptives increases your risk of clot in the leg (DVT) which would cause one-sided leg swelling and is an urgent medical issue. However, swelling of both legs may occur—without a DVT—from the estrogen component in oral contraceptives. If you do have edema, a progesterone-only option is worth looking into, after your doctor has ruled out a DVT.
- Oral steroids, like prednisone, are often prescribed for asthma or COPD exacerbation, severe rash or allergic reactions, and many autoimmune diseases. Prednisone causes sodium retention and may lead to lower extremity edema.
- Pioglitazone (Actos) and rosiglitazone (Avandia) are medications used in the treatment of diabetes. Lower extremity swelling is a well described side effect of these two diabetes meds so if you are experiencing lower leg edema, ask about a change to another newer medication for diabetes.
Hope this helps